FDA Product Code QTW: Digital Amsler Grid
A Digital Amsler Grid Is Intended As An Aid In Detection Of Central Visual Irregularities Caused By Changes In The Visual Pathway In Patients.
Leading manufacturers include Neuro-Eye Diagnostic Systems, LLC.
1
Total
1
Cleared
637d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Digital Amsler Grid Devices (Product Code QTW)
1 devices
About Product Code QTW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QTW since 2022, with 1 receiving FDA clearance (average review time: 637 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QTW devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →